PMA P140019S010
- Device
- I-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S010
- Product code
- NOX
- Decision date
- 2023-12-15
- Classification
- Orthopedic
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- a change to manufacturing to introduce a new supplier for bovine bone used to produce anorganic bone mineral (ABM)
Current openFDA PMA Record#
- Device
- I-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S010
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2023-12-15
- Decision code
- OK30
- Date received
- 2023-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to manufacturing to introduce a new supplier for bovine bone used to produce anorganic bone mineral (ABM)